Status:
COMPLETED
Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal insulin glargine and once-daily prandial insulin lispro, in participants with Type 2 Diabetes.
Eligibility Criteria
Inclusion
- Present with type 2 diabetes mellitus
- Have been taking metformin and/or pioglitazone
- Have received treatment with basal insulin glargine, injected once a day, for greater than or equal to 90 days
- Have glycosylated hemoglobin A1c (HbA1c) concentration between greater than or equal to 7.5% and less than or equal to 10.5
- Have a fasting plasma glucose concentration of less than or equal to 6.7 millimoles per liter \[mmol/L, less than or equal to 121 milligrams per deciliter (mg/dL)\], or greater than 6.7 mmol/L (greater than 121 mg/dL) if the investigator considers that further titration of basal insulin glargine is not possible for safety reasons
- Not pregnant or breastfeeding
Exclusion
- Have Type 1 Diabetes
- Their stable dose of pioglitazone is greater than the maximum dose approved for use in combination with insulin in their country
- Have a body mass index (BMI) greater than 45 kilograms per square meter (kg/m2).
- Have a history of scheduled mealtime (prandial) insulin use within 12 weeks of the screening visit and the total duration of the prandial insulin treatment was greater than 2 weeks
- Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study
- Have cardiac disease with a functional status that is Class III or IV
- Have a history of renal or liver disease
- Have had a blood transfusion or have a blood disorder
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
478 Patients enrolled
Trial Details
Trial ID
NCT01175824
Start Date
April 1 2011
End Date
November 1 2012
Last Update
February 24 2014
Active Locations (18)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mar del Plata, Argentina, B7600FZN
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ramos Mejía, Argentina, B1704ETD
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Porto Alegre, Brazil, 90035-170
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
São Paulo, Brazil, 01244-030